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The FDA reminded in vitro diagnostic (IVD) makers that they must get Institutional Review Board (IRB) approval for clinical studies of IVDs that involve human subjects, including those using leftover, deidentified human specimens in FDA-regulated studies. Read More
The clinical trial will evaluate 263 patients who are being treated at two vertebral levels either with the M6-C disc or with discectomy and fusion. Read More
The randomized multicenter study will gauge the device’s ability to safely reduce intra- or postoperative cerebrospinal fluid leakage in patients undergoing cranial surgery. Read More
The FlowTriever system has received both FDA 510(k) clearance and CE mark certification for treating pulmonary embolisms and clots in the heart’s right atrium. Read More
The FDA’s Center for Drug Evaluation and Research (CDER) issued a warning letter to Foshan Biours Biosciences, a combination drug/device manufacturing facility in Guangdong, China, following a records-based inspection that revealed inadequate testing and cleaning validation for the company’s biomedical patch. Read More
The trial is evaluating the procedure’s ability to grant durable insulin-free glycemic control in patients who aren’t getting adequate control on insulin therapy. Read More
The SleepHub device works by playing scientifically formulated sounds through high- quality speakers, using specific beats and pulses to help modulate sleep patterns and emulate brain waves produced during sleep. Read More